FDA (Devices) recall action 85701

Biomet recalled 22 products on 2020-06-17

The FDA (Devices) publishes a recall like this one as 22 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 22 pages.

Products: 22
Announced: 2020-06-17
Critical: 0
Units: 315

Why these products were recalled

Distributed to the field without having completed design history files or design transfer activities

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–22 of 22

ModerateFDA (Devices)··2020-06-17
Biomet A.L.P.S. Proximal Humerus Plating System Drill Bit Recalled
Biomet is recalling A.L.P.S. Proximal Humerus Plating System 3.2mm Calibrated Drill Bits because they were distributed without completed design history files or design transfer activities.
Product
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM CALIBRATED DRILL BIT, Item Number: 110017737 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Category
Distribution
5 states
ModerateFDA (Devices)··2020-06-17
Biomet Recalls Proximal Humerus Plating System Due to Incomplete Design Files
Biomet is recalling 16 units of the A.L.P.S. Proximal Humerus Plating System because they were distributed without completed design history files or design transfer activities.
Product
A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 14 HOLE 227MM, Item Number: 110030109 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Category
Distribution
5 states
ModerateFDA (Devices)··2020-06-17
Biomet 8.0 Cannulated Screw Tap Recalled for Incomplete Design History Files
Biomet is recalling 8.0 Cannulated Screw Taps because they were distributed without completed design history files or design transfer activities.
Product
Biomet 8.0 Cannulated Screw Tap-Bone fixation screw Item Number: 110008467 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Category
Distribution
5 states
ModerateFDA (Devices)··2020-06-17
Biomet Recalls A.L.P.S. Proximal Humerus Plating System Drill Block Guide Sleeve
Biomet is recalling A.L.P.S. Proximal Humerus Plating System Drill Block Guide Sleeves because they were distributed without completed design history files or design transfer activities.
Product
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 2.7MM, Item Number: 110017563 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Category
Distribution
5 states
ModerateFDA (Devices)··2020-06-17
Biomet A.L.P.S. Proximal Humerus Plating System Recalled for Design Documentation Deficiencies
Biomet is recalling A.L.P.S. Proximal Humerus Plating System units distributed without completed design history files or design transfer activities.
Product
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 14 HOLE 227MM, Item Number: 110030209 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Category
Distribution
5 states
ModerateFDA (Devices)··2020-06-17
Biomet Recalls Proximal Humerus Plate Templates Due to Incomplete Design History
Biomet is recalling 78 units of A.L.P.S. Proximal Humerus Plate Templates because they were distributed without completed design history files or design transfer activities.
Product
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 90MM, Item Number: 110025471 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Category
Distribution
5 states
ModerateFDA (Devices)··2020-06-17
Biomet Recalls Proximal Humerus Plating System Due to Incomplete Design History
Biomet is recalling A.L.P.S. Proximal Humerus Plating System units because they were distributed without completed design history files or design transfer activities.
Product
A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 11 HOLE 190MM, Item Number: 110030108 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Category
Distribution
5 states
ModerateFDA (Devices)··2020-06-17
Biomet A.L.P.S. Proximal Humerus Plating System Recalled for Design History Deficiencies
Biomet is recalling A.L.P.S. Proximal Humerus Plating System units because they were distributed without completed design history files or design transfer activities.
Product
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 11 HOLE 197MM, Item Number: 110030308 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Category
Distribution
5 states
ModerateFDA (Devices)··2020-06-17
Biomet 6.5 Cannulated Screw Tap Recalled for Incomplete Design History
Biomet is recalling 6.5 Cannulated Screw Taps because they were distributed without completed design history files or design transfer activities.
Product
Biomet 6.5 Cannulated Screw Tap - Bone fixation screw, Item Number: 110008466 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Category
Distribution
5 states
ModerateFDA (Devices)··2020-06-17
Biomet A.L.P.S. Proximal Humerus Plating System Recalled for Design History Deficiencies
Biomet is recalling A.L.P.S. Proximal Humerus Plating System units because they were distributed without completed design history files or design transfer activities.
Product
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 14 HOLE 234MM, Item Number: 110030409 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Category
Distribution
5 states
ModerateFDA (Devices)··2020-06-17
Biomet Recalls Proximal Humerus Plating System Due to Design History Deficiencies
Biomet is recalling the A.L.P.S. Proximal Humerus Plating System because it was distributed without completed design history files or design transfer activities.
Product
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 11 HOLE 190MM, Item Number: 110030208 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Category
Distribution
5 states
HighFDA (Devices)··2020-06-17
Biomet A.L.P.S. Proximal Humerus Plating System Drill Block Set Screw Recalled
Biomet is recalling A.L.P.S. Proximal Humerus Plating System Drill Block Set Screws because they were distributed without completed design history files or design transfer activities.
Product
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK SET SCREW, Item Number: 110017551 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Category
Distribution
5 states
ModerateFDA (Devices)··2020-06-17
Biomet A.L.P.S Proximal Humerus Plating System Drill Block Guide Sleeve Recalled
Biomet is recalling A.L.P.S Proximal Humerus Plating System Drill Block Guide Sleeves because they were distributed without completed design history files or design transfer activities.
Product
A.L.P.S PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 3.2MM, Item Number: 110017553 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Category
Distribution
5 states
ModerateFDA (Devices)··2020-06-17
Biomet Recalls A.L.P.S. Proximal Humerus Plating System for Design Documentation Issues
Biomet is recalling A.L.P.S. Proximal Humerus Plating System plates because they were distributed without completed design history files or design transfer activities.
Product
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 14 HOLE 234MM, Item Number: 110030309 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Category
Distribution
5 states
ModerateFDA (Devices)··2020-06-17
Biomet A.L.P.S. T15 Multi-Directional Locking Screw Recalled for Design History Deficiencies
Biomet is recalling A.L.P.S. T15 Multi-Directional Locking Screws because they were distributed without completed design history files or design transfer activities.
Product
A.L.P.S. T15 Multi-Directional Locking Screw 3.5mm x 60mm, Item Number: 110017960 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Category
Distribution
5 states
ModerateFDA (Devices)··2020-06-17
Biomet A.L.P.S. Proximal Humerus Plating System Locking Pegs Recalled
Biomet is recalling A.L.P.S. Proximal Humerus Plating System 3.2mm Locking Pegs 60mm because they were distributed without completed design history files or design transfer activities.
Product
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM LOCKING PEG 60MM , Item Number: 110025460 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Category
Distribution
5 states
ModerateFDA (Devices)··2020-06-17
Biomet Proximal Humerus Plating System Recalled for Design History Deficiencies
Biomet is recalling A.L.P.S. Proximal Humerus Plating System units because they were distributed without completed design history files or design transfer activities.
Product
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 7 HOLE 140MM, Item Number: 110030307 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Category
Distribution
5 states
ModerateFDA (Devices)··2020-06-17
Biomet Recalls Proximal Humerus Plate Templates Due to Incomplete Design History
Biomet is recalling A.L.P.S. Proximal Humerus Plate Templates because they were distributed without completed design history files or design transfer activities.
Product
A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 140MM Item Number: 110025472 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Category
Distribution
5 states
ModerateFDA (Devices)··2020-06-17
Biomet Recalls Proximal Humerus Plating System Due to Incomplete Design History
Biomet is recalling specific lots of the A.L.P.S. Proximal Humerus Plating System because they were distributed without completed design history files or design transfer activities.
Product
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 7 HOLE 140MM, Item Number: 110030407 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Category
Distribution
5 states
ModerateFDA (Devices)··2020-06-17
Biomet A.L.P.S. Cortical Screw Recalled for Incomplete Design History
Biomet is recalling A.L.P.S. T15 Low Profile Cortical Screws because they were distributed without completed design history files or design transfer activities.
Product
A.L.P.S. T15 LOW PROFILE CORTICAL SCREW 3.5mm x 28mm, Item Number: 110017628 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Category
Distribution
5 states
ModerateFDA (Devices)··2020-06-17
Biomet Recalls Proximal Humerus Plate Templates Due to Incomplete Design Files
Biomet is recalling A.L.P.S. Proximal Humerus Plate Templates because they were distributed without completed design history files or design transfer activities.
Product
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 234MM Item Number: 110025473 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Category
Distribution
5 states
ModerateFDA (Devices)··2020-06-17
Biomet Recalls Proximal Humerus Plating System Due to Incomplete Design Files
Biomet is recalling the A.L.P.S. Proximal Humerus Plating System because units were distributed without completed design history files or design transfer activities.
Product
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 11 HOLE 197MM, Item Number: 110030408 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Category
Distribution
5 states